Cellectis enters into an agreement with CELLforCURE for the cGMP manufacturing of allogeneic CART cells
Published on June 09, 2014
June 9, 2014 – Paris & Les Ulis, France – Cellectis (Alternext: ALCLS.PA), a leader in the development of adoptive immunotherapies based on engineered allogeneic CART cells (UCART) and CELLforCURE, the largest commercial industrial facility for the production of innovative therapeutic cell therapies in Europe, a subsidiary of the biopharmaceutical group LFB, announce that they have entered into an agreement for the cGMP manufacturing of clinical batches of Cellectis’ allogeneic CART cells.
Pursuant to this agreement, CELLforCURE will be responsible for the manufacturing of cGMP clinical batches for candidates from Cellectis’ UCART product family.
The candidates from UCART (for Universal Chimeric Antigen Receptor – T cells) product family are allogeneic cell therapy products based on the CAR (Chimeric Antigen Receptor) technology combined with genome engineering. Engineered allogeneic T-lymphocytes bearing a CAR directed at a tumor antigen stand out as a genuine therapeutic innovation in the treatment of various forms of leukemias, lymphomas and solid tumors.
UCARTs are special in that they are “off-the-shelf” allogeneic products. This brings major advantages over the autologous procedures currently undergoing clinical testing. UCARTs’ production can be industrialized and thereby standardized, with consistent pharmaceutical release criteria, over time and from batch to batch. Each future patient may thus be treated by immediately receiving a single dose of a standard product with consistent quality. The favorable cost of such industrially manufactured treatments may help making them available to a broad patient population and avoiding risks associated with the processing and the timing required for an autologous CART process. In addition, such allogeneic products may be shipped in advance and would be accessible to any cancer center in the world without the need to invest on a local CART processing facility.
Dr Mathieu Simon, MD, Executive Vice President at Cellectis stated: “We are very pleased of this partnership with CELLforCURE, a unique brand-new industrial platform dedicated to cell therapies and equipped with a state-of-the-art GMP manufacturing facility. It will ensure that Cellectis will have, in the long term, the means for the clinical development of its UCART product family and will add robustness to our ongoing regulatory applications. Moreover, it is a new way to manufacture cost-effectively CART cell products, and thus making them broadly and immediately available to patients. cGMP manufacturing of allogeneic CART cells is a paradigm change in cancer adoptive immunotherapies.”
Pierre-Noël Lirsac, CEO of CELLforCURE declared: “This partnership, signed with a company such as Cellectis, confirms the fast development of innovative therapies and the relevance of an industrial platform to manufacture these new treatments. We are proud to contribute to Cellectis’ efforts, thanks to the flexibility of our large scale facility, aiming at developing this innovative treatment in oncology based on a brand new technology."